Status:
COMPLETED
A Study of LY3164530 in Participants With Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
- Have adequate organ function.
- Prior Treatments:
- Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
- Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
- Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
- Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
- If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
- If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.
- Exclusion Criteria:
- Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
- Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
- Must not have a serious preexisting medical conditions or concomitant disorders.
- Must not have leukemia.
- Must not have QT interval of \>470 millisecond.
- Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2017
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02221882
Start Date
August 1 2014
End Date
March 7 2017
Last Update
October 23 2019
Active Locations (3)
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1
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
The START Center for Cancer Care
San Antonio, Texas, United States, 78229